According to the CFDA, the pharmaceutical companies have to pass the current GMP to get their facility and medicine registration for marketing within this year. Only four months left and a great amount of medical and small pharmaceutical companies have been busy working on the issue. A technical staff of a large pharmaceutical company told the journalist that the new GMP is strict and not all the companies will get the new certificate.

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Benefit From The New GMP

The pharmaceutical and the biologics companies who produce blood product, vaccine and injection shall get the new GMP certificate by the end of Dec. 31^st, 2013. The other pharmaceutical companies have to get the certificate by the end of 2015. For those that fail the inspection and do not get the new GMP certificate, they have to stop all the production.

Professor Dong Yuli from ENT research center of Armed Police Hospital said, "GMP has been the production and commercial license for the pharmaceutical companies since 1998, when the CFDA was first established. The old version of the GMP is not as strict as the new version and lack of enough information to regulate the pharmaceutical companies. It is known that we have too many similar products under the same category, along with companies' chaotic and unorganized managements. Some of the products are not designed and produced in the required way to ensure the safety and effectiveness. For example, the Herba Houttuyniae injection, Shuanghuanglian injection and the Qingkailing injection that do not comply with the purification regulation cause server adverse events. Professor Wang Tong from the ER department of Sun Yat Sen Memorial Hospital agreed with government's determination that they will inspect the pharmaceutical companies that produce blood product, vaccine and the injection. Since these medicines will contact the blood and immune system it is quite important to source them via the new GMP.

Challenge and Change for The Pharmaceutical Companies

The new GMP is similar to the GMP in US and EU and modified based on our condition. Some regulations even require more than the GMP of US and EU. The pharmaceutical companies which have a good GMP system before would probably get the inspection pass. In addition, they will share the market from those small companies that do not pass the new GMP inspection. In the other hand, the new GMP does concern many small and medical size pharmaceutical companies. One owner of those companies is cleaning up the product these days and is going to work in the sale field in the future. The higher requirement means better equipment and more investment, which is the toughest part for those small and middle size pharmaceutical companies. The investment includes the new equipment of the product chain, the human source and time and would be up to 150 billion.